Wed, Nov 08, 2017 - Page 10 News List

UK might turn to FDA for help after Brexit: lawmaker

Bloomberg

If the UK cannot reach an accord regarding new drug approvals by the European Medicines Agency (EMA) following Brexit, the government might consider looking to the US for support.

“That is not our desired outcome,” British lawmaker James O’Shaughnessy said at the Bio-Europe conference in Berlin on Monday.

The UK wants to continue to benefit from its relationship with the EMA, he said, but added that “there are approvals being made by other stringent regulators.”

At issue is the question of whether the UK can avoid the expense and challenges involved in taking over the task of reviewing and approving hundreds of drugs for use in the country once it leaves the EU in March 2019.

Pharmaceutical industry executives have advocated reaching a pact that would essentially allow for mutual recognition of new medicines between the EMA and the British Medicines and Healthcare products Regulatory Agency, thereby eliminating the need to replicate processes and reducing costs for drugmakers.

Without such a deal, companies might opt to introduce new drugs in the UK, home to about 66 million people, only after they have tapped the US, continental Europe and other, bigger markets.

The EMA is poised to move away from its London headquarters and end its oversight of the British market after Brexit.

The US Food and Drug Administration (FDA) is sometimes faster than the EMA in approving new medicines, and FDA Commissioner Scott Gottlieb aims to speed up the process even further.

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